Malfunction; CatheterPhase 4PROCOPrt-PANCT01670474
Prolonged Hemodialysis Catheter Survival With Copolymer Coating and Rt-PA
A Phase 4 study testing rt-PA (2mg/2mL) actilysis and rt-PA in people with Malfunction; Catheter and Thrombosis, run by Centre Hospitalier du Centre du Valais at 1 site in Switzerland.
Trial summary
Surface thrombogenicity of standard double lumen catheters (stDLC) and surface modified film-coated domain structured double lumen catheters (fcDLC) consisting of a novel reactive polyurethane copolymer coating showed that in vitro measured surface thrombogenicity was reduced in the modified catheter compared with… Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Malfunction; Catheter, Thrombosis, Mechanical Complication of Hemodialysis Catheter
- What is being tested?
- rt-PA (2mg/2mL) actilysis and rt-PA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2011to Nov 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- End-stage kidney disease patients with newly inserted temporary untunnelled dual-lumen catheter
- Naive to study but not naive to catheters (both virgin and non-virgin catheters will be included)
- Expected to use catheter, and to dialyze at study centre, for at least six months
- Frequency of HD 3 times per week
- If indication for catheter was replacement for catheter related infection patients will be eligible after the infection has been treated and the patient has been off antibiotics for 3 HD sessions
- Patient or legal representative able to provide written consent
Show all 9Show fewer
- Eighteen years of age or older
- Baseline INR ≤ 1.3 (no anticoagulation allowed outside the HD session)
- Baseline platelet count ≥ 60 x 109/L
Who cannot join
- Use of systemic anticoagulation (if indication for anticoagulation is catheter patency patients may be eligible if the systemic anticoagulation is discontinued and baseline INR is ≤ 1.3)
- Insertion of a new catheter into the femoral vein
- Current use of antibiotics for catheter-related bacteraemia (see inclusion criteria above)
- Major haemorrhage in the prior 4 weeks, defined as bleeding resulting in a drop in haemoglobin of greater than 20 g/L or bleeding requiring transfusion of packed red blood cells with other clinical evidence or suspicion of bleeding
- History of intra-cranial bleed in the prior 4 weeks
- Intra-cranial or intra-spinal neoplasm (current)
Show all 14Show fewer
- Allergy or intolerance to rt-PA or heparin or its constituents
- Active pericarditis - defined by the presence of a pericardial rub
- Weight ≤ 30 kg or > 130 kg
- Patient pregnant or lactating
- Child bearing potential (i.e. pre-menopausal woman who is not using a reliable method of contraception)
- Major surgery in past 48 hours (CABG, organ biopsy, puncture of non-compressible vessels), or scheduled for major surgery during the study period
- Involvement in another randomized drug trial
- Presence of a fever as defined by a temperature > 38.2°C
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Centre Hospitalier du Centre du Valais (CHCVs)
Sion, Valais, 1950
Pascal Meier, MD, +41276038647, pascal.meier@hopitalvs.ch
Rachel Meier, SN
About this study
Official title: Prolonged Hemodialysis Catheter Survival With Copolymer Coating and Rt-PA - PROCOPrt-PA Trial
Surface thrombogenicity of standard double lumen catheters (stDLC) and surface modified film-coated domain structured double lumen catheters (fcDLC) consisting of a novel reactive polyurethane copolymer coating showed that in vitro measured surface thrombogenicity was reduced in the modified catheter compared with standard catheter. The clinical investigation revealed that both number of days before catheter removal according to clinical requirements and number of treatments per catheter were significantly higher with the modified catheter as compared with the standard catheter.
Recombinant tissue plasminogen activator (rt-PA) has been used primarily to treat catheter thrombosis. The relatively high cost of rt-PA and its theoretical potential to cause bleeding, as well as the morbidity and mortality associated with catheter malfunction and infection, justify the need for more definitive evidence of the efficacy of rt-PA as a locking solution.
No study aims to evaluate the impact of rt-PA locking in long-term Hemodialysis (HD) uncuffed catheters survival.
Read the detailed description
The solution instilled into the central venous catheter lumens after each HD session and left in the catheter until the next session (catheter locking solution) is used to prevent thrombosis during the period between HD sessions and may also prevent catheter-related infection. However, evidence supporting the use of various locking solutions to achieve these objectives is limited. Heparin has been the traditional locking solution. Several small studies have assessed whether citrate and heparin are equally efficacious for maintaining catheter patency but the interpretation of the results was limited because the studies had a short follow-up period and included both uncuffed and cuffed central venous catheters.
Thrombosis is a major cause of HD catheter dysfunction, and this problem is rectified by the use of thrombolytic agents, invasive procedures for declotting, or catheter replacement. A thrombus at the tip of the catheter or a fibrin sheath around it may resist local thrombolysis if it is not reached by sufficient concentrations of the drug. Urokinase has traditionally been used as the thrombolytic agent for HD vascular access declotting, and success rates for declotting vary from 55% to 85%. However, successful treatment of occluded central venous catheter (non HD) with recombinant tissue plasminogen activator (rt-PA) or alteplase was recently achieved in more than 1,000 patients with success (function restored in 798 patients [75.0%; 95% CI: 72.3 to 77.6%]). Serious adverse events monitored within 30 days was very rare and efficacy was independent of age, sex, body weight, and catheter type.
- Being tested
- rt-PA (2mg/2mL) actilysis, rt-PA
- Keywords
- Temporary hemodialysis catheters, Non-cuffed hemodialysis catheters, Thrombolysis, rt-PA, Thrombosis, Lifespan, Blood flow rate, Catheter related bacteriemia
- Medical subject headings
- Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rt-PA (2mg/2mL) actilysisDrug
Also called Cathflo, 2mg/2mL (Boehringer Ingelheim, Ingelheim/Germany
At the first catheter dysfunction (Qb < 250 ml/min) due to thrombotic event, the patient will receive rt-PA (2mg/2mL Alteplase vial - Cathflo, Boehringer Ingelheim, Ingelheim, Germany). Each lumen of the thrombosed catheter is locked with the exact volume (luminal volume) of rt-PA during 45 min. All catheters analyzed (fmDLC, polyDLC and siDLC) will be locked with the exact volume (luminal volume) of rt-PA during 45 min. Each catheter analyzed will be filled with rt-PA (2mg/2mL) if they are dysfunctional as described above in Arm/Group Descriptions: i.e. fmDLC, polyDLC amd siDLC.
rt-PADrug
Also called Cathflo, 2mg/2mL (Boehringer Ingelheim, Ingelheim/Germany)
At the first catheter dysfunction (Qb < 250 ml/min) due to thrombotic event, the patient will receive rt-PA (2mg/2mL Alteplase vial - Cathflo, Boehringer Ingelheim, Ingelheim, Germany). Each lumen of the thrombosed catheter is locked with the exact volume (luminal volume) of rt-PA during 45 min. Each catheter analyzed in this study (i.e. fmDLC, polyDLC, siDLC) will be filled with rt-PA (2mg/2mL) if they are dysfunctional as described above in Arm/Group Descriptions.
| Study group | Role | What they receive |
|---|---|---|
| fmDLC and rt-PA (2mg/2mL actilysis) | Experimental | Surface thrombogenicity of film-coated domain structured double lumen catheters (fmDLC) consisting of a novel reactive polyurethane copolymer coating will be assessed by measurement of thrombin-antithrombin (TAT) III complex in vitro after the use of rt-PA (2mg/2mL) in each lumen of the catheter for 45 minutes.
Each lumen of the thrombosed (dysfunctional) catheter will be locked with the exact volume (luminal volume) of rt-PA (rt-PA (2mg/2mL) actilysis) during 45 min. Receives: Drug: rt-PA (2mg/2mL) actilysis; Drug: rt-PA |
| polyDLC and rt-PA (2mg/2mL actilysis) | Active comparator | The same procedure will be assessed in the polyurethane double lumen catheter (polyDLC)as with the fmDLC. Indeed, surface thrombogenicity of polyDLC will be assessed by measurement of thrombin-antithrombin (TAT) III complex in vitro after the use of rt-PA (2mg/2mL) in each lumen of the catheter for 45 minutes.
Each lumen of the thrombosed (dysfunctional) catheter will be locked with the exact volume (luminal volume) of rt-PA (rt-PA (2mg/2mL) actilysis) during 45 min. Receives: Drug: rt-PA (2mg/2mL) actilysis; Drug: rt-PA |
| siDLC and rt-PA (2mg/2mL actilysis) | Active comparator | Same procedure as the previous catheters. Surface thrombogenicity of silicone double lumen catheter (siDLC) will be assessed by measurement of thrombin-antithrombin (TAT) III complex in vitro after the use of rt-PA (2mg/2mL) in each lumen of the catheter for 45 minutes.
Each lumen of the thrombosed (dysfunctional) catheter will be locked with the exact volume (luminal volume) of rt-PA (rt-PA (2mg/2mL) actilysis) during 45 min. Receives: Drug: rt-PA (2mg/2mL) actilysis; Drug: rt-PA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lifespan patency with the ability to complete HD session in three different UCs using rt-PA locking protocol
The ability to achieve blood flow rates of >= 250 mL/min in three different UCs using rt-PA locking protocol if the UCs present a clotting event (complete or partial thrombosis).
Measured: 240 days after patients' enrollement
Secondary outcomes (2)
The incidence of catheter-related bacteremia after rt-PA use in case of thrombosed UCs
The solution instilled into the central venous catheter lumens after each HD session and left in the catheter until the next session (catheter locking solution) is used to prevent thrombosis during the period between HD sessions and may also prevent catheter-related infection.
Measured: 240 days after patients' enrollement
Economic evaluation of rt-PA in catheter patency after UCs dysfunction
An economic evaluation of rt-PA in catheter patency after dysfunction (partial or complete catheter thrombosis) will be conducted.
Measured: 240 days after patients' enrollement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2012 (estimated)
- Study startJan 2011
- Primary completionNov 2012 (estimated)
- Study completionNov 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Malfunction; CatheterStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier du Centre du Valais
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pascal Meier MD, Centre Hospitalier du Centre du Valais
- Investigators
- Pascal Meier, MD, Principal investigator, CHCVs - RSV - Hôpital du Valais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01670474
- Sponsor's protocol ID
- PROCOPrt-PA
- Other IDs
- Cath-a-lysis
- Acronym
- PROCOPrt-PA
- Status last verified
- Aug 2012
- First submitted
- 20 Mar 2012
- Last updated
- 22 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Meier P, Meier R, Turini P, Friolet R, Blanc E. Prolonged catheter survival in patients with acute kidney injury on continuous renal replacement therapy using a less thrombogenic micropatterned polymer modification. Nephrol Dial Transplant. 2011 Feb;26(2):628-35. doi: 10.1093/ndt/gfq449. Epub 2010 Jul 28.
PubMed 20667989
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prolonged Hemodialysis Catheter Survival With Copolymer Coating and Rt-PA - PROCOPrt-PA Trial
- ClinicalTrials.gov ID
- NCT01670474
- Acronym / sponsor ID
- PROCOPrt-PA / PROCOPrt-PA
- Keywords
- Temporary hemodialysis catheters, Non-cuffed hemodialysis catheters, Thrombolysis, rt-PA, Thrombosis, Lifespan, Blood flow rate, Catheter related bacteriemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Centre Hospitalier du Centre du ValaisUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Nov 2012 (estimated)
- Study completion
- Nov 2012 (estimated)
- First posted
- 22 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Surface thrombogenicity of standard double lumen catheters (stDLC) and surface modified film-coated domain structured double lumen catheters (fcDLC) consisting of a novel reactive polyurethane copolymer coating showed that in vitro measured surface thrombogenicity was reduced in the modified catheter compared with standard catheter. The clinical investigation revealed that both number of days before catheter removal according to clinical requirements and number of treatments per catheter were significantly higher with the modified catheter as compared with the standard catheter.
Recombinant tissue plasminogen activator (rt-PA) has been used primarily to treat catheter thrombosis. The relatively high cost of rt-PA and its theoretical potential to cause bleeding, as well as the morbidity and mortality associated with catheter malfunction and infection, justify the need for more definitive evidence of the efficacy of rt-PA as a locking solution.
No study aims to evaluate the impact of rt-PA locking in long-term Hemodialysis (HD) uncuffed catheters survival.
Detailed description
The solution instilled into the central venous catheter lumens after each HD session and left in the catheter until the next session (catheter locking solution) is used to prevent thrombosis during the period between HD sessions and may also prevent catheter-related infection. However, evidence supporting the use of various locking solutions to achieve these objectives is limited. Heparin has been the traditional locking solution. Several small studies have assessed whether citrate and heparin are equally efficacious for maintaining catheter patency but the interpretation of the results was limited because the studies had a short follow-up period and included both uncuffed and cuffed central venous catheters.
Thrombosis is a major cause of HD catheter dysfunction, and this problem is rectified by the use of thrombolytic agents, invasive procedures for declotting, or catheter replacement. A thrombus at the tip of the catheter or a fibrin sheath around it may resist local thrombolysis if it is not reached by sufficient concentrations of the drug. Urokinase has traditionally been used as the thrombolytic agent for HD vascular access declotting, and success rates for declotting vary from 55% to 85%. However, successful treatment of occluded central venous catheter (non HD) with recombinant tissue plasminogen activator (rt-PA) or alteplase was recently achieved in more than 1,000 patients with success (function restored in 798 patients [75.0%; 95% CI: 72.3 to 77.6%]). Serious adverse events monitored within 30 days was very rare and efficacy was independent of age, sex, body weight, and catheter type.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| fmDLC and rt-PA (2mg/2mL actilysis) | Experimental | Drug: rt-PA (2mg/2mL) actilysis, Drug: rt-PASurface thrombogenicity of film-coated domain structured double lumen catheters (fmDLC) consisting of a novel reactive polyurethane copolymer coating will be assessed by measurement of thrombin-antithrombin (TAT) III complex in vitro after the use of rt-PA (2mg/2mL) in each lumen of the catheter for 45 minutes. Each lumen of the thrombosed (dysfunctional) catheter will be locked with the exact volume (luminal volume) of rt-PA (rt-PA (2mg/2mL) actilysis) during 45 min. |
| polyDLC and rt-PA (2mg/2mL actilysis) | Active comparator | Drug: rt-PA (2mg/2mL) actilysis, Drug: rt-PAThe same procedure will be assessed in the polyurethane double lumen catheter (polyDLC)as with the fmDLC. Indeed, surface thrombogenicity of polyDLC will be assessed by measurement of thrombin-antithrombin (TAT) III complex in vitro after the use of rt-PA (2mg/2mL) in each lumen of the catheter for 45 minutes. Each lumen of the thrombosed (dysfunctional) catheter will be locked with the exact volume (luminal volume) of rt-PA (rt-PA (2mg/2mL) actilysis) during 45 min. |
| siDLC and rt-PA (2mg/2mL actilysis) | Active comparator | Drug: rt-PA (2mg/2mL) actilysis, Drug: rt-PASame procedure as the previous catheters. Surface thrombogenicity of silicone double lumen catheter (siDLC) will be assessed by measurement of thrombin-antithrombin (TAT) III complex in vitro after the use of rt-PA (2mg/2mL) in each lumen of the catheter for 45 minutes. Each lumen of the thrombosed (dysfunctional) catheter will be locked with the exact volume (luminal volume) of rt-PA (rt-PA (2mg/2mL) actilysis) during 45 min. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- End-stage kidney disease patients with newly inserted temporary untunnelled dual-lumen catheter
- Naive to study but not naive to catheters (both virgin and non-virgin catheters will be included)
- Expected to use catheter, and to dialyze at study centre, for at least six months
- Frequency of HD 3 times per week
- If indication for catheter was replacement for catheter related infection patients will be eligible after the infection has been treated and the patient has been off antibiotics for 3 HD sessions
Key exclusion criteria (14 listed)
- Use of systemic anticoagulation (if indication for anticoagulation is catheter patency patients may be eligible if the systemic anticoagulation is discontinued and baseline INR is ≤ 1.3)
- Insertion of a new catheter into the femoral vein
- Current use of antibiotics for catheter-related bacteraemia (see inclusion criteria above)
- Major haemorrhage in the prior 4 weeks, defined as bleeding resulting in a drop in haemoglobin of greater than 20 g/L or bleeding requiring transfusion of packed red blood cells with other clinical evidence or suspicion of bleeding
- History of intra-cranial bleed in the prior 4 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rt-PA (2mg/2mL) actilysisAlso: Cathflo, 2mg/2mL (Boehringer Ingelheim, Ingelheim/GermanyAt the first catheter dysfunction (Qb < 250 ml/min) due to thrombotic event, the patient will receive rt-PA (2mg/2mL Alteplase vial - Cathflo, Boehringer Ingelheim, Ingelheim, Germany). Each lumen of the thrombosed catheter is locked with the exact volume (luminal volume) of rt-PA during 45 min. All catheters analyzed (fmDLC, polyDLC and siDLC) will be locked with the exact volume (luminal volume) of rt-PA during 45 min. Each catheter analyzed will be filled with rt-PA (2mg/2mL) if they are dysfunctional as described above in Arm/Group Descriptions: i.e. fmDLC, polyDLC amd siDLC. | Drug | fmDLC and rt-PA (2mg/2mL actilysis), polyDLC and rt-PA (2mg/2mL actilysis), siDLC and rt-PA (2mg/2mL actilysis) |
| rt-PAAlso: Cathflo, 2mg/2mL (Boehringer Ingelheim, Ingelheim/Germany)At the first catheter dysfunction (Qb < 250 ml/min) due to thrombotic event, the patient will receive rt-PA (2mg/2mL Alteplase vial - Cathflo, Boehringer Ingelheim, Ingelheim, Germany). Each lumen of the thrombosed catheter is locked with the exact volume (luminal volume) of rt-PA during 45 min. Each catheter analyzed in this study (i.e. fmDLC, polyDLC, siDLC) will be filled with rt-PA (2mg/2mL) if they are dysfunctional as described above in Arm/Group Descriptions. | Drug | fmDLC and rt-PA (2mg/2mL actilysis), polyDLC and rt-PA (2mg/2mL actilysis), siDLC and rt-PA (2mg/2mL actilysis) |
Primary outcome
Lifespan patency with the ability to complete HD session in three different UCs using rt-PA locking protocol
Time frame: 240 days after patients' enrollement
The ability to achieve blood flow rates of >= 250 mL/min in three different UCs using rt-PA locking protocol if the UCs present a clotting event (complete or partial thrombosis).
2 secondary outcomes
The incidence of catheter-related bacteremia after rt-PA use in case of thrombosed UCs
Time frame: 240 days after patients' enrollement
Economic evaluation of rt-PA in catheter patency after UCs dysfunction
Time frame: 240 days after patients' enrollement
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2012.
- Results publication: PubMed 20667989Meier P, Meier R, Turini P, Friolet R, Blanc E. Prolonged catheter survival in patients with acute kidney injury on continuous renal replacement therapy using a less thrombogenic micropatterned polymer modification. Nephrol Dial Transplant. 2011 Feb;26(2):628-35. doi: 10.1093/ndt/gfq449. Epub 2010 Jul 28.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pascal Meier, MD principal investigator
CHCVs - RSV - Hôpital du Valais
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing rt-PA (2mg/2mL) actilysis and rt-PA in people with Malfunction; Catheter and Thrombosis, run by Centre Hospitalier du Centre du Valais at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pascal Meier, MD (+41276038647, pascal.meier@hopitalvs.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lifespan patency with the ability to complete HD session in three different UCs using rt-PA locking protocol (time frame: 240 days after patients' enrollement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01670474, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2012; AzTrials last refreshed its copy on 8 Nov 2026.